Software and Programming Tools in Pharmaceutical Research

Quality by Design in Pharmaceutical Development: Current Advances and Future Prospects

Author(s): Popat Mohite*, Amol Gholap, Sagar Pardeshi, Abhijeet Puri and Tanavirsing Rajput

Pp: 68-107 (40)

DOI: 10.2174/97898152230191240100006

* (Excluding Mailing and Handling)


QbD, or Quality by Design, is a cutting-edge methodology adopted extensively in the pharmaceutical industry. It is defined objects, such as the product's safety and effectiveness. QbD's primary focus in the pharmaceutical industry is ensuring the product's security and usefulness. Quality by Design (QbD) seeks to instill high standards of excellence in the blueprinting process. The International Council for Harmonization (ICH) has developed guidelines and elements that must be adhered to guarantee the consistent, high-quality development of pharmaceuticals. This chapter provides updated guidelines and elements, including quality risk management, pharmaceutical quality systems, QbD in analytical methods and pharmaceutical manufacturing, process control, vaccine development, pharmacogenomic, green synthesis, etc. QbD was briefly defined, and several design tools, regulatory-industry perspectives, and QbD grounded on science were discussed. It was portrayed that significant effort was put into developing drug ingredients, excipients, and manufacturing processes. Quality by design (QbD) is included in the manufacturing process's development, and the result is steadily improving product quality. Quality target product profiles, critical quality attributes, analytical process techniques, critical process parameters control strategy and design space are elements of many pharmaceutical advancements. Some of the topics covered included the application of QbD to herbal products, food processing, and biotherapeutics through analytical process techniques. We are still exploring and compiling all the data and metrics required to link and show the benefits of QbD to all stakeholders. Nevertheless, the pharmaceutical sector is quickly using the QbD process to create products that are reliable, efficient, and of high quality. Soon, a more profound comprehension of the dosage form parameters supported by the notion of QbD will benefit Risk management and process and product design, optimizing complex drug delivery systems.

Keywords: Drug delivery system, Process and product design, Quality by design, Risk management.

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